Clinical Trial to Compare Clear Aligners' Auxiliaries on Rotational Accuracy

A Randomized Clinical Trial to Compare the Influence of Optimized Attachments, IPR and a Combination of Both Techniques on the Rotational Accuracy of Canines With Clear Aligners

This randomized clinical trial aims to assess the effectiveness of optimized attachments, IPR and a combination of the two techniques on the rotational accuracy of canines with clear aligners

Study Overview

• Status: Completed
• Conditions: Rotation of Tooth
• Intervention / Treatment: Device: auxiliary

Detailed Description

Study Visit 1 (V1): Upon fitting the inclusion criteria, the patient will be randomized to one of the four interventional groups. A member of the study team will collect the initial orthodontics records. These records include two radiographs (a panoramic radiograph and a lateral cephalogram), intraoral and extraoral photographs, and an iTero intraoral digital scan. The scan will be sent directly to the Align Technology Invisalign doctor platform to begin the process of fabricating the desired aligners according to the clinical instructions for the simulated treatment plan by the study team and the randomly assigned group for the patient. Study Visit 2 (V2): 5 weeks following visit 1, Invisalign aligners will be delivered to the included and randomized subjects, and associated treatment rendered. Subjects will be instructed to wear their aligners full-time except while eating, drinking, and brushing and change their aligners as recommended by Invisalign® every week. Study Visit 3 (V3): The trial will end after the patient has completed wearing the first stage of aligners. Final records will be collected: these include iTero intraoral digital scans to construct the 3D digital models, intraoral and extraoral photographs, and radiographs.

To assess the accuracy of the achieved outcomes and compare the outcomes of the four treatment groups, the collected digital models (predicted simulated models and achieved final scanned models) will be superimposed and compared to assess the accuracy and predictability of rotational tooth movement in the included subjects, and treatment outcomes will be evaluated. The differences between the positions of each tooth in the two digital models (predicted from Clincheck and achieved from the final scan) will quantified for rotation: differences of 2° or more rotation will be considered clinically relevant. These values were chosen from the American Board of Orthodontics (ABO) model grading system for case evaluation and other clinical studies.5 Additionally, data related to treatment duration, number of aligners, and number of visits needed to complete the treatment will be gathered and analyzed in a de-identified form.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

• Physically healthy with no relevant allergies or medical problems
• Male or female above 18 years old
• Full permanent dentition except for the third molars
• Any type of malocclusion with rotated canines that require derotation
• Good oral hygiene and absence of periodontal disease
• Malocclusion to be treated with Invisalign aligners (SmartTrack)
• Any ethnic group

Exclusion Criteria

• Orthognathic surgical cases
• An extraction treatment plan
• Poor oral hygiene
• Patients with syndromes or craniofacial anomalies.
• The use of any other orthodontic appliance than clear aligners' (Invisalign)
• Malocclusion that requires auxiliaries in the simulated plan ( buttons and elastics on the canines)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No Interproximal reduction or attachments will be used to help correct the rotation
Experimental: Inter proximal reduction; Interproximal reduction will be performed in this arm	Device: auxiliary; the interventions are related to the adjuncts associated with clear aligners to improve the predictability and accuracy of tooth movement
Experimental: Optimized attachments; optimized composite attachments will be added to this arm	Device: auxiliary; the interventions are related to the adjuncts associated with clear aligners to improve the predictability and accuracy of tooth movement
Experimental: IPR and optimized attachments; Both Interproximal reduction will be implemented and optimized attachments will be added to this arm	Device: auxiliary; the interventions are related to the adjuncts associated with clear aligners to improve the predictability and accuracy of tooth movement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Canine rotation	3D model superimposition will be used to assess the accuracy of tooth movement	6-9 months

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): December 15, 2025
• Study Completion (Actual): December 28, 2025

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IRB202400491

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes